A potent painkiller, and the drug maker’s marketing, are faulted in a woman’s death

Family photos of Sarah Fuller from youth to adulthood, including several with her fiancé, Don Brown.Matthew Orr/STAT

STRATFORD, N.J. — There was a stranger waiting for Sarah Fuller when she visited her doctor to discuss switching medications for her back and neck pain — a saleswoman pitching a prescription version of the potent opioid fentanyl.

The drug, called Subsys, is so powerful, and the risk of addiction and overdose so formidable, that the Food and Drug Administration requires doctors to undergo special training before they are allowed to prescribe it. And it has approved Subsys only for cancer patients who suffer intense flares of pain.

Fuller didn’t have cancer. She had been in two car accidents and been diagnosed with painful fibromyalgia. Yet her physician “let the sales rep start talking about helping her with the pain,” David Fuller, who accompanied his daughter to the appointment, told STAT.

Sarah's father, David, was present when his daughter met with Dr. Vivienne Matalon and the sales rep from Insys.

Just over a year after that January 2015 office visit, 32-year-old Sarah Fuller was found dead in her bedroom by her fiance. The county medical examiner ruled her death the result of the “adverse effect of drugs.” A toxicology screen revealed a level of fentanyl in her blood that experts consulted by STAT said is lethal. There was also a small amount of the anti-anxiety medication Xanax in her system.

Synthetic forms of fentanyl, most of it illegally shipped from China, have flooded into the US and Canada in the past year, causing hundreds of overdose deaths. But Sarah Fuller’s case shows that the prescription version of the drug can also be dangerous when it’s prescribed “off-label” for conditions it’s not approved for — and that Insys Therapeutics sales reps have encouraged doctors to do just that.

“They killed her,” Sarah’s mother, Deborah Fuller, said of those involved in putting her daughter on a high-dose regimen of fentanyl, which is up to 100 times more potent than morphine. “You took a beautiful girl getting ready for her wedding, something she dreamed of.”

There is no indication her fentanyl use and subsequent death was from anything other than the legal drug she was prescribed for her pain, said Richard Hollawell, a Marlton, N.J., attorney hired by Sarah’s family to investigate her death. He said the family plans legal action against both Insys and Dr. Vivienne Matalon, the Cherry Hill, N.J., physician who prescribed the Subsys.

Telephone messages and emails to Insys’s public relations representative and a company official were not returned. Matalon did not return multiple messages left at her office and home.

Sarah's mother, Deborah, says Matalon and the sales rep are responsible for her daughter's death.

While doctors are allowed to prescribe drugs for off-label conditions, drug makers aren’t permitted to promote medications for these purposes. Insys, based in Chandler, Ariz., is under investigation by several state attorneys general and federal prosecutors for the marketing of Subsys, according to disclosures the company has made in public securities filings. On Thursday, federal prosecutors in Connecticut charged a former Insys district sales manager, whose territory included New Jersey, with allegedly paying kickbacks to doctors to get them to prescribe fentanyl.

Insys has already settled one case, in Oregon. The attorney general there alleged Insys was “implicitly misrepresenting to patients that Subsys should be used to treat migraine, neck pain, back pain, and other off-label uses for which Subsys is neither safe nor effective.” Subsys settled the case last year by making a payment of $1.1 million. It did not admit to any improper behavior.

In addition, both an Insys sales rep in Alabama and a nurse in Connecticut have pleaded guilty to federal kickback charges related to off-label Subsys prescribing. Those cases alleged that doctors and a nurse were paid kickbacks by company employees to prescribe the drug. The sales rep in Alabama was paid a base salary of $40,000 but received more than $700,000 in commissions from 2013 to 2015 based on the volume of off-label prescriptions written by doctors she called on, according to court records.

The aggressive and illegal marketing of Subsys comes as the country deals with an epidemic of opioid addiction. It follows other instances of the illegal marketing of opioids that have been blamed for helping to fuel the crisis. In 2007, Purdue Pharma, the maker of the painkiller OxyContin, pleaded guilty to a criminal charge related to its marketing of the drug and paid more than $600 million in fines.

“We have created a system by which [drug] companies go out and break the law, they may or may not get caught, and if they do get caught, they are just going to pay a settlement,” said Eric Campbell, a professor of health policy at Harvard Medical School who also is as an expert witness for the federal government in an ongoing off-label marketing case. “The settlement they pay is going to be less than they make doing these activities. It is just like parking tickets on delivery trucks.”

Sarah Fuller is not the only Subsys patient who is alleged to have died from taking the prescription drug. A case filed in July in Jacksonville, Fla., alleges Carolyn Markland died in 2014, only hours after taking Subsys in her doctor’s office. She was being treated for chronic back pain.

Subsys is the only brand-name drug Insys sells. In 2011, the year before it hit the marketplace, Insys was operating at a loss with no reported revenue. Last year, company revenues were $330 million and it reported a profit of $58.5 million.

The company recently announced that its founder, John Kapoor, would be stepping down as chief executive. According to a March financial filing, Kapoor is the largest shareholder in the company, with a stake valued at just under $600 million based on the most recent closing price of Insys shares.

Sarah's parents describe how opioids changed their daughter.

Sarah first started to heavily use painkillers following an auto accident a decade ago, her family said during an interview inside the modest ranch-style home where Sarah lived just outside Philadelphia.

Her car was broad-sided by another vehicle and she suffered several herniated discs in her back and neck. Just two years earlier, her vehicle had been hit from behind at a stop sign. That accident also left her with spinal pain.

It was not long before she was completely dependent on the drugs. She was on so many medications that in 2014, her kidneys failed, according to father, a baker, and her mother, who worked as an office administrator.

Her family said Sarah’s personality and physical condition changed after she became a chronic user of opioids. As a child, she was a standout soccer player. After high school, she worked for several years as an aide at nursing homes. She would frequently pick up extra hours, working back-to-back shifts for additional money. She enjoyed going out with friends.

On the drugs, she was lethargic and unmotivated, her family said. She gained 100 pounds. Walking even as far as the length of the driveway proved difficult. She would spend days in her pajamas and slippers, with the shades drawn.

A printout of her prescriptions from a local Rite Aid pharmacy, beginning in mid-2007 and continuing until her death in March, runs 122 pages. There are 974 individual prescriptions listed, many of them for 30-day supplies and some for longer. The drugs include the painkillers OxyContin and Percocet, antidepressants, and anti-anxiety medications.

Sarah received her first shipment of Subsys on Jan. 9, 2015: a box with a 20-day supply of the 200-microgram dose of the drug, delivered by FedEx. Medicare, which covered Sarah after she was determined to be disabled following a second car accident, paid $5,509 for the prescription, according to a pharmacy billing ledger.

The following month, Sarah’s dosage of Subsys was tripled to 600 micrograms, and the cost to Medicare doubled. In August 2015, Sarah started to receive 30 days of supply instead of 20. Her last delivery was on March 22, 2016, just three days before she died. The box contained 180 doses of Subsys at a cost of $19,657 to Medicare.

The last box of Subsys medication that was delivered to Sarah Fuller.Richard Hollawell

During the 15 months Sarah was on Subsys, Medicare paid $250,544 for the Subsys she was prescribed, according to a billing ledger prepared by Linden Care, a Woodbury, N.Y., specialty pharmacy.

After starting to take fentanyl, her need for opioids was more intense. Subsys is administered by a spray under the tongue and rapidly enters the bloodstream. It is intended to be taken every four hours. Sarah would set her alarm during the night to make sure she woke up to take a dose on time. If she waited longer than four hours, she would start to shake and become agitated. The drug also intensified feelings of depression, her family said.

She would take additional doses at times. Some months, she would run out before her next delivery arrived. To get her through the days she didn’t have Subsys, Sarah would take OxyContin she was also prescribed, her mother said.

Dr. Adriane Fugh-Berman, a physician and Georgetown University professor who helped the District of Columbia develop training programs for opioid prescribers, said the high doses of fentanyl prescribed to Fuller were likely inappropriate.

“They don’t work well for chronic pain,” she said of drugs like Subsys. Over the long-term, daily use of high doses of fentanyl can reduce oxygen levels in the blood. The respiratory system is depressed, and Fugh-Berman said it is not uncommon for some people on heavy doses of opioids to die in their sleep.

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Asked about the presence of the Insys drug rep in the doctor’s meeting with Fuller, Fugh-Berman called it a “new level of outrageous behavior and inappropriateness.”

Hollawell, the lawyer representing the Fuller family, said he confirmed the sales rep was at the meeting from notes kept in Sarah’s medical file at her doctor’s office.

The amount of fentanyl found in Sarah’s blood after she died was 15 to 20 times the therapeutic level and well above rates considered lethal, said Dr. Lewis Nelson, the chair of emergency medicine at Rutgers New Jersey Medical School. “This is clearly a fentanyl death,” he said.

“It’s very possible she was just on this drug chronically and overdosed a little bit,” Nelson said. “She either took too much by accident or by purpose.”

Subsys, Nelson added, is being “marketed well beyond its indicated use.”

Another thing to consider is the fact that Xanax was also found upon toxicological examination. Doctors really need closely monitor patients that are taking opiates along with a benzodiazepine. Most prescription opioid deaths involve the person taking a benzodiazepine.

The author of this article needs to do a little research: “Synthetic forms of fentanyl, most of it illegally shipped from China, have flooded into the US and Canada in the past year…)—ALL forms of fentanyl are synthetic! It is a nonsensical statement.

Not all drug reps are bad people. Years ago I was telling my pain management doctor that the insurance company refused my medication ,which is their standard practice. A rep from Insys overheard the conversation,the door was open, and after an interview, filling out forms and a discussion with my doctor I was able to try subsys. My injury is very severe and was already used to another product, Actiq. The dangers were the same but so were the benefits. I’ve been dealing with chronic pain for 28 years and the best results I experienced have been with Subsys and before that Actiq. I was able to start living again . But every thing comes to an end.After taking Actiq for almost 2 years and years later Subsys for about 7or8 months I could not afford them after the trial period ended .But they did work very well and it was the most pain free I have ever been.

.Not all drug reps are bad people like the story would like you to believe. Years ago I was telling my pain management doctor that Liberty Mutual once again did not aprove my medication,which they do quite often and a rep from Insys overheard my story.She asked me questions,I completed forms and she discussed my situation with the doctor. In about a week I recieved my first order of Subsys.I was told all about the dangers of the drug and I understood them as well as the benefits. The warnings are the same as Actiq which at one time was prescribed to me for a very serious ,extremely complicated and extremely painful back injury. The subsys worked great and I felt relief I hadn’t experienced in years. I will always remember Insys and the time they helped me by giving me the medication for almost 6 months for free. The same for the makers of Actiq who supplied me with their fentanyl suckers for a long time. I was injured in 1990 and the best pain relief came from Actiq and Subsys. Unfortunately the medicine is to expensive for me,Actiq was over $3,000 a month while the high dose of Subsys I was taking cost $28,000 a month. I went to morphine sulfate and oxy contin. While I still felt a lot of pain I managed to find the combination which allowed me to start enjoying life again. All the time NOT abusing my medication. Now that has come to an end months ago with this unfair,inhumane cutback.I’m sorry that some people abuse their drugs and they pay the ultimate price not to mention the pain and suffering their family’s go through.But some of us manage our medications in a responsible way and we should not be penalized for it. The fentanyl described was ment for cancer patients but turned out to be a Godsend for my chronic pain. I’m sorry I could not afford it. The little amount of medication I receive now does nothing for my pain and I spend money on black market oxy. That is the only alternative now that the cutback is in place. The only ones happy are the guys that sell the pills and the insurance company’s who run the workers comp system. The ones that are supposed to be under their care now live the most painful and lack of quality existence ever imaginable. How can this decision be the right one for everyone. And if people can’t find alternatives what are they left with? The insurance company mentioned hasn’t offered any alternatives nor do they care how much pain I am in.They have even cut back my medicine further the same day the doctor cut it back. Double cutbacks in one day,no easing one off of the drugs just severe cuts. The doctors won’t stand up for their patients, the attorneys get paid through the workers comp system,the workers comp system is run by insurance company’s and the insurance company’s don’t care about the people in the system that they are supposed to be helping. Then the assholes from the DEA get involved to make sure that chronic pain patients live a miserable existence. It doesn’t matter that they paid taxes all their life or served their country . We get to finish our lives in severe pain. Everything about this sucks. USA USA USA?

The new guidelines are no more than 100mg opioids a day which is such a huge dose amount of opioids!! Why can’t these chronic pain patients understand that when they are cut off of SubSys 600micrograms 3x a day and also on Oxycodone ER 80mg a day and many times also Norco and more oxycodone a day, that the pain they are still in when they are given cutbacks by their doctors that its not their pain from their Chronic Pain condition its OPIOID WITHDRAWALS which are extremely painful with a feeling of extreme depression. I’ve known many patients including myself who take their pain meds as described by their doctor and STILL die and/or still become addicted to opioids. And these patients including myself have cancer! So stop saying I got my life back when I was on a huge dose of opioids a day. Its the opioids making you very happy and experiencing no pain that’s what being high on opioids does so stop lying to yourself that its the pain from your Chronic Pain condition and it also stops your opioid withdrawals everyday also making you happy and feeling very good and that’s why people use drugs to feel happy and feel no pain. You are no different than a heroin user but instead of a illegal dealer you get your drugs from a doctor so in your mind its different, right?!! So get help and getting a higher dose of opioids is NOT getting help, you need rehab!!!! We see right thru you cuz I was the SAME EXACT WAY!!

According to the story this woman was unfortunately abusing the medication prescribed to her. It’s this kind of behavior that has the DEA and the CDC to put into policy the inhumane guidelines that limit chronic pain patients to only 100mg of medication a day. This new policy not only leaves me in intense pain all day long it has destroyed what little quality of life I have left. I cannot do what I used to do and I avoid contact with people because I’m tired of explaining my situation when asked how things are going. They see in my face and my actions that I am not doing well.Not all drug reps are bad people like the story would like you to believe. Years ago I was telling my pain management doctor that Liberty Mutual once again did not aprove my medication,which they do quite often and a rep from Insys overheard my story.She asked me questions,I completed forms and she discussed my situation with the doctor. In about a week I recieved my first order of Subsys.I was told all about the dangers of the drug and I understood them as well as the benefits. The warnings are the same as Actiq which at one time was prescribed to me for a very serious ,extremely complicated and extremely painful back injury. The subsys worked great and I felt relief I hadn’t experienced in years. I will always remember Insys and the time they helped me by giving me the medication for almost 6 months for free. The same for the makers of Actiq who supplied me with their fentanyl suckers for a long time. I was injured in 1990 and the best pain relief came from Actiq and Subsys. Unfortunately the medicine is to expensive for me,Actiq was over $3,000 a month while the high dose of Subsys I was taking cost $28,000 a month. I went to morphine sulfate and oxy contin. While I still felt a lot of pain I managed to find the combination which allowed me to start enjoying life again. All the time NOT abusing my medication. Now that has come to an end months ago with this unfair,inhumane cutback.I’m sorry that some people abuse their drugs and they pay the ultimate price not to mention the pain and suffering their family’s go through.But some of us manage our medications in a responsible way and we should not be penalized for it. The fentanyl described was ment for cancer patients but turned out to be a Godsend for my chronic pain. I’m sorry I could not afford it. The little amount of medication I receive now does nothing for my pain and I spend money on black market oxy. That is the only alternative now that the cutback is in place. The only ones happy are the guys that sell the pills and the insurance company’s who run the workers comp system. The ones that are supposed to be under their care now live the most painful and lack of quality existence ever imaginable. How can this decision be the right one for everyone. And if people can’t find alternatives what are they left with? The insurance company mentioned hasn’t offered any alternatives nor do they care how much pain I am in.They have even cut back my medicine further the same day the doctor cut it back. Double cutbacks in one day,no easing one off of the drugs just severe cuts. The doctors won’t stand up for their patients, the attorneys get paid through the workers comp system,the workers comp system is run by insurance company’s and the insurance company’s don’t care about the people in the system that they are supposed to be helping. Then the assholes from the DEA get involved to make sure that chronic pain patients live a miserable existence. It doesn’t matter that they paid taxes all their life or served their country . We get to finish our lives in severe pain. Everything about this sucks. USA USA USA?

There is a definite need for Drs and pain clinics who can and will prescribe off-label for those w/chronic uncontrollable pain, but this Dr went overboard. We need more available means to deal with this issue because being in pain all the time can also ill you.

This woman was a joneser who could not handle being medicated. I have a condition far more serious and i got by on morphine for 25 years. Then people like her get 250 thousandd dollars worth of fenta-ill and she needs oxxies on top of that too???? Wtf? Now my insurance is cutting everyone off op8s because of ding dongs like her that od’ed. At least she passed on heavily medicated while 1000s of pain mngt people are suffering with no meds due to this whole opiophobia media hyped up crap fest.

I agree.. there’s a heroin epidemic not an pride mic for people who actually need their medications and who take them
Responsibly. I’m disgusted that I must always feel like the bad guy when I’m in so much pain and the only thing that will help me now is my pain medication. Start by removing dealers off the seeets and leave the legitimate patients alone!

So your upset bc you can’t get your hands on more pain killers like she could? Why you wanna kill yourself too? And don’t go all you don’t know on me, I know more about all this and how it works than most doctors. From the brain receptors to the 4 different type of operators, to the medication bioavailability. My wife has cancer, I’ve had chronic back pain for years, my brother has cancer, and I help all of them talk to their doctors to make the correct decisions. And you know what is the most sickening thing of all, when people are more empathetic towards getting their pain medication or a higher dose of it than when another person looses their life. These drugs are schedule 2 for a reason and part of that is their addiction, and addiction is a clinical disease, whether it’s chemical, physical or mental. Perhaps you may think you are only physically or chemically dependent but she had a mental addiction and perhaps your right. But you know what I see, when someone is blaming someone else’s death in another part of the u.s. for the fact that they can’t get more medication… addiction, lack of empathy, projecting blame onto others, and all in all selfishness. Does that sound like an addict to you? How about all the studies that are convincing insurance companies that opioids don’t help chronic pain non cancer related health conditions. I don’t believe those studies are true, but don’t blame the victim, unless you have used Subsys or fentora or actiq you don’t what your getting yourself into. And yeah when people die, if I were a doctor I would be more careful too, I wouldn’t want wrongful death law suits. Especially when it could be anyone, maybe a pain patient of mine who has been on morphine for 25 years, decided to take a sleeping pill one night or drink too much too, or maybe they drank grapefruit juice and took an herb like saint johns wart and then they wernt feeling it work like usual so they took more meds sooner than they were supposed to but they had a build up in their system from the grapefruit and herb and it all released at once, or maybe their kidney started to fail and no one knew causing less filteration and higher potency for the patient without them knowing. I get a lot of real people in need don’t over it do it, and respect the drug and it’s danger, I’m one of them. But my point is, it can happen to someone without even knowing. And more importantly this is not the place to air concerns like that. You can obviously say what you want, it’s your right, but in my opinion doing so just makes you look like a jerk.

So many of the comments here are entirely consistent in both substance and language with the arguments made by those who still see merit in fighting the failed war on drugs. The criminals here are the delinquent physician, sales rep & entire system of (de)regulation that aim successfully to convince people that it’s only fair that the free market be allowed to govern health care and that health care should be astronomically profitable before being mildly compassionate, safe and sane.

As someone who has so far been lucky enough not to become addicted to any prescribed or recreational substances, I read stories like these and see no reason (other than chance) why this could not happen to me. I look at my children in all of their college-bound youth and see no reason (other than chance) why it could not happen to them. I can only hope that they’ll pass through that intersection a few seconds before the car that would crash into them, that if they should be in that car accident, the pain can be managed conservatively and, if it can’t, that they encounter doctors who won’t cynically prey on them for a free meal, a free vacation or a fat check.

I’m not religious but I can’t think of any better description than “there but by the grace of God go I”. The fentanyl prescribed in an outpatient setting in the quantities described here seems like it has overwhelming potential for addiction, overdose and death rather than being merely a compelling substance with moderate addiction potential. This wasn’t about will power, meetings, or bootstraps and personal responsibility; this young woman was handed a likely overdose in prescription form by a board licensed professional in a white coat who knew better, who owed her a duty of care first and foremost, and who cynically failed her for payment.

My condolences go to Sarah’s family. I’m very sorry for your loss and for all of the unimaginable pain you’ve had to endure.